An interventional study of Different anesthesia methods, namely local anesthesia and general anesthesia in Intracranial Aneurysm, sponsored by Ming Lv. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Ming Lv · Not applicable, Interventional, and Treatment
The prevalence of unruptured intracranial aneurysm (UIA) in the population is about 2%-7%, and once it ruptures and bleeds, the rate of disability and death is extremely high, with 10%-15% of patients dying suddenly before they can seek medical attention, 35% of first-time bleeders, and 60%-80% of second-time bleeders. Survivors are often disabled. Therefore, there is a broad consensus that UIA with surgical indication should be aggressively intervened. The efficacy and safety of flow diverter (FD) in the treatment of UIA has been confirmed by many large clinical trials. Currently, FD placement for UIA is performed under general anesthesia (GA) in most centers, however, some studies have observed that FD placement under local anesthesia (LA) is not as effective as FD placement under general anesthesia and have demonstrated the feasibility of FD placement under local anesthesia (LA) with high technical success rates and low perioperative complication rates and mortality. However, the retrospective design and relatively limited sample size of the above studies may introduce significant bias and affect the confidence of the conclusions. Therefore, the present trial was designed as a randomized controlled trial with the aim of comparing the safety and efficacy of GA and LA in UIA patients undergoing FD placement. The results of this study will help inform future multicenter trials to validate the impact of anesthesia choice on the safety and efficacy in UIA patients undergoing FD placement.
427 studies on the registry are indexed under Intracranial Aneurysm; 115 are open to participants now.
This study's planned enrollment of 188 is above the median of 110 across 207 interventional studies indexed under Intracranial Aneurysm.
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Exclusion Criteria:
Patients in the local anesthesia group received only local anesthesia at the femoral artery puncture site without anesthesia drugs such as conscious sedation.
Other: Different anesthesia methods, namely local anesthesia and general anesthesia
Patients in the general anesthesia group received not only local anesthesia at the femoral artery puncture site, but also fast-induction anesthesia with tracheal intubation or laryngeal mask insertion using propofol, remifentanil, and rocuronium.
Other: Different anesthesia methods, namely local anesthesia and general anesthesia
Patients in the local anesthesia group received only local anesthesia at the femoral artery puncture site without anesthesia drugs such as conscious sedation. Patients in the general anesthesia group received not only local anesthesia at the femoral artery puncture site, but also fast-induction anesthesia with tracheal intubation or laryngeal mask insertion using isoproterenol, remifentanil, and muscle relaxants.
Good neurologic status
Defined as an mRS score of ≤2 (i.e., asymptomatic or without significant disability)
Time frame: 90 days after intervention
Newly developed cerebral ischemic foci
Determination was based on DWI sequences of cranial MRI
Time frame: Within 48 hours of flow diverter placement
Status of cognitive function
Cognitive functioning status assessed by the Montreal Cognitive Assessment (MoCA). The MoCA was developed by Prof. Nasreddine in 2004 as a rapid screening tool for mild cognitive impairment.The MoCA has a total score of 30, with a minimum score of 0. Higher scores indicate better cognitive functioning. By scoring each domain, more detailed information can be obtained to determine the extent of deficits and abnormalities in cognitive functioning. In general, a score of 26 and above can be considered normal cognitive functioning, while a score below 26 may indicate the presence of cognitive impairment or dementia. 18-26 is considered mild cognitive impairment, 10-17 is considered moderate cognitive impairment, and \<10 is considered severe cognitive impairment.
Time frame: 90 days after intervention
Postoperative perioperative complication rate
The perioperative period is defined as up to 7 days after the intervention
Time frame: 7 days after intervention
Overall complication rate at 90 days postoperatively
Overall complication rate at 90 days postoperatively
Time frame: 90 days after intervention
Mortality at 90 days post-intervention
Mortality at 90 days post-intervention
Time frame: 90 days after intervention
Proportion of local anesthesia converted to general anesthesia during interventional procedures
For patient safety, patients in LA will be referred to GA if they develop the following conditions a) The patient becomes comatose and unconscious; b) Glasgow coma scale (GCS) \<8; c) EtCO2 ≥ 60 mmHg or SpO2 \< 94% despite supplemental oxygen; d) Patient has vomiting, vertigo, agitation that is not controlled by antiemetics and sedation; e) Seizures; f) Complications of endovascular therapy, such as intracerebral hemorrhage from a ruptured aneurysm or SAH.
Time frame: Immediately after intervention
Anesthesia induction time, time from femoral artery puncture to femoral artery suture, anesthesia recovery time, and total operative time
Record the above times in the immediate postoperative period
Time frame: Immediately after surgery
Incidence of intraoperative vasospasm
Incidence of intraoperative vasospasm
Time frame: Immediately after surgery
Pain scores at 24 hours postoperatively
Measured with a VAS ranging from 0 (no pain) to 10 (intolerable)
Time frame: 24 hours after intervention
Pain medication use within 24 hours after surgery
Pain medication use within 24 hours after surgery
Time frame: 24 hours after intervention
Length of hospitalization
Length of hospitalization
Time frame: Until the patient was discharged from the hospital, an average of 1 week.
Hospitalization costs
Hospitalization costs
Time frame: Until the patient was discharged from the hospital, an average of 1 week.
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